BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, LLC, the 7th largest generic drug
manufacturer in the U.S. market, has received U.S. FDA approval for one
of the first generic versions of Suboxone® sublingual tablets
for maintenance treatment of opioid drug dependence. Generic
buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual
tablets are now available in 2 mg/0.5 mg and 8 mg/2 mg strengths, both
in 30-count bottles. The Amneal medication is bioequivalent to Suboxone®
(a registered trademark of Reckitt Benckiser Healthcare (UK) Limited
(LSE:RB)). Annual U.S. sales of Suboxone® in all dosage forms
are $1.5 billion, according to December 2012 IMS Health market data.

Providing opioid-dependent patients with high quality generic
buprenorphine HCl and naloxone HCl through treatment in physicians’
offices, treatment centers, or prescriptions filled at retail pharmacies
offers tremendous cost savings for both consumers and the U.S.
healthcare system, while delivering the same therapeutic effect as the
brand medication. To help their patients take advantage of this lower
cost alternative, physicians should clearly indicate “buprenorphine HCl
and naloxone HCl tablets” or “Suboxone® tablets” when writing
prescriptions to avoid confusion at the pharmacy. Patients currently
using any form of Suboxone® should ask their doctors or
dispensing pharmacists for buprenorphine HCl and naloxone HCl sublingual
tablets to get the cost-saving generic version with a pleasant orange
flavor.

In addition to patients and their prescribing physicians, a more
cost-effective opioid addiction treatment should be welcome news to
insurance companies, the Centers for Medicare and Medicaid Services, the
Veterans Health Administration and other payors, pharmacy benefits
managers (PBMs), managed care facilities, drug addiction and recovery
organizations and treatment advocacy groups as well. Generic drugs are
saving the U.S. healthcare system one billion dollars every other day,
according to the Generic Pharmaceutical Association.

“The FDA’s decision to approve the first generic equivalents to Suboxone®
sublingual tablets will ensure that millions of patients in the U.S. who
need this product now have access to a high quality, low cost generic
version,” said Chirag Patel, President and Co-Chairman of Amneal. “Since
the agency has issued its opinion on Reckitt Benckiser’s September 2012
Citizen’s Petition in favor of generic competition, Amneal’s
buprenorphine HCl and naloxone HCl tablets can offer consumers and
physicians greater choice in opioid addiction treatment. We are also
pleased that the FDA has referred this matter to the Federal Trade
Commission to investigate and address Reckitt’s anticompetitive business
practices.”

“We appreciate the FDA’s thorough assessment of Reckitt’s Citizen’s
Petition and applaud their recent decision to deny it in its entirety,”
said Chintu Patel, Amneal CEO and Co-Chairman. “The FDA determined that
Reckitt’s petition did not raise valid scientific or regulatory issues
associated with the product, which Amneal contended in its comments on
the petition. Physicians should have no concerns in writing
prescriptions for the generic tablet form of the product.”

Manufactured in Amneal’s fully FDA-compliant Brookhaven, NY facility,
buprenorphine HCl and naloxone HCl tablets will be available through
wholesalers and distributors as well as directly to the trade. The
product received FDA approval under an approved Risk Evaluation and
Mitigation Strategy (REMS), known as the Buprenorphine-containing
Transmucosal products for Opioid Dependence (BTOD) REMS program, and
will be distributed in accordance with FDA and U.S. Drug Enforcement
Administration (DEA) regulations governing the handling of CIII
controlled substances. The generic tablets will be available to patients
when the BTOD REMS program becomes operational in early March.

Amneal Pharmaceuticals, LLC is a U.S.-based manufacturer of generic
pharmaceuticals. Known as “Generic’s New Generation,” Amneal prides
itself on its unwavering commitment to quality, meaningful business
relationships, and innovative approach to maximizing value for all
stakeholders. Extensive investment in R&D, an intelligently aggressive
expansion strategy, and focus on vertical integration are key
contributors to the company’s impressive growth over the past several
years. Amneal is headquartered in Bridgewater, New Jersey with
manufacturing, R&D, packaging, sales and distribution facilities
throughout the U.S., as well as abroad. For more information, visit
amneal.com.